U.S. patent application number 13/043775 was filed with the patent office on 2012-09-13 for tracheal tube connector devices and methods.
This patent application is currently assigned to Nellcor Puritan Bennett LLC. Invention is credited to Roger Harrington, Seamus Maguire, James Stephenson, Paul Waldron.
Application Number | 20120227746 13/043775 |
Document ID | / |
Family ID | 46794389 |
Filed Date | 2012-09-13 |
United States Patent
Application |
20120227746 |
Kind Code |
A1 |
Harrington; Roger ; et
al. |
September 13, 2012 |
TRACHEAL TUBE CONNECTOR DEVICES AND METHODS
Abstract
Various embodiments of tracheostomy tube assemblies including a
cannula, a cap, and a flange are provided. The cannula includes a
distal end and a proximal end, the distal end being adapted to be
inserted into a patient's trachea. The annular cap includes an
annular body having a first surface adapted to be received into the
proximal end of the cannula to retain a portion of the cap in the
annular body. The flange member includes a second surface that
engages the proximal end of the cannula such that the proximal end
of the cannula is retained between the second surface of the flange
member and the first surface of the annular cap. The flange member
also includes a third surface adapted to engage an inner surface of
the annular body of the annular cap to retain the flange member
between the annular cap and the proximal end of the cannula.
Inventors: |
Harrington; Roger; (Athlone,
IE) ; Waldron; Paul; (Galway, IE) ;
Stephenson; James; (Galway, IE) ; Maguire;
Seamus; (Athlone, IE) |
Assignee: |
Nellcor Puritan Bennett LLC
Boulder
CO
|
Family ID: |
46794389 |
Appl. No.: |
13/043775 |
Filed: |
March 9, 2011 |
Current U.S.
Class: |
128/207.14 ;
156/60; 29/428 |
Current CPC
Class: |
B29C 66/7392 20130101;
B29C 66/71 20130101; A61M 16/0497 20130101; Y10T 29/49826 20150115;
B29C 66/73151 20130101; B29L 2023/007 20130101; Y10T 156/10
20150115; B29C 66/5344 20130101; B29C 66/71 20130101; B29C 66/71
20130101; B29C 66/71 20130101; A61M 16/04 20130101; B29K 2075/00
20130101; B29K 2027/06 20130101; B29K 2021/003 20130101; A61M
16/0434 20130101; B29C 65/4895 20130101; B29C 66/71 20130101; A61M
2207/00 20130101; A61M 16/0816 20130101; B29C 57/02 20130101; B29C
65/48 20130101; B29K 2069/00 20130101 |
Class at
Publication: |
128/207.14 ;
156/60; 29/428 |
International
Class: |
A61M 16/04 20060101
A61M016/04; B32B 37/02 20060101 B32B037/02; B23P 11/00 20060101
B23P011/00; B32B 37/12 20060101 B32B037/12 |
Claims
1. A tracheostomy tube assembly, comprising: a cannula comprising a
distal end and a proximal end, the distal end being adapted to be
inserted into a patient's trachea; an annular cap comprising an
annular body having a first surface configured to be received into
the proximal end of the cannula; and a flange member comprising a
second surface configured to engage the proximal end of the cannula
to retain the proximal end between the second surface of the flange
member and the first surface of the annular cap, wherein the flange
member further comprises a third surface configured to engage an
inner surface of the annular body of the annular cap to retain the
flange member between the annular cap and the proximal end of the
cannula.
2. The tracheostomy tube assembly of claim 1, wherein the first
surface comprises an annular protrusion configured to facilitate
the retention of a portion of the cap in the proximal end of the
cannula.
3. The tracheostomy tube assembly of claim 1, wherein the proximal
end of the cannula is flared and the first surface of the cap is
tapered to complement the flared end of the cannula.
4. The tracheostomy tube assembly of claim 1, wherein the second
surface comprises an annular protrusion configured to create an
interference fit between the flange member and the proximal end of
the cannula.
5. The tracheostomy tube assembly of claim 1, wherein the third
surface of the flange member comprises one or more annular
protrusions configured to create an interference fit between the
inner surface of the annular body and the flange member.
6. The tracheostomy tube assembly of claim 1, wherein the inner
surface of the annular body and the flange member are coupled with
an adhesive material.
7. The tracheostomy tube assembly of claim 1, wherein the proximal
end of the cannula and the second surface of the flange member are
solvent bonded.
8. The tracheostomy tube assembly of claim 1, wherein the cap is
made of a hard thermoplastic material.
9. The tracheostomy tube assembly of claim 8, wherein the cap is
made of acrylonitrile butadiene styrene.
10. A method of forming a tracheal tube assembly, comprising:
assembling a cap to a cannula, the cap comprising an outer wall and
a nipple portion together defining an internal cavity, the nipple
portion of the cap contacting an inner diameter of a proximal end
of the cannula; and assembling a flange to the assembled cap and
cannula with a portion of the flange contacting the internal cavity
of the cap between the outer wall and the proximal end of the
cannula.
11. The method of claim 10, further comprising securing the nipple
portion of the cap to the proximal end of the cannula by solvent
bonding.
12. The method of claim 10, further comprising securing the flange
to the outer wall of the cap by applying an adhesive material to
the flange.
13. The method of claim 10, further comprising securing the
proximal end of the cannula to the flange via solvent bonding.
14. The method of claim 10, wherein the cap is formed from a rigid
thermoplastic material.
15. The method of claim 10, wherein the proximal end of the cannula
is flared such that the diameter of the proximal end increases
along the length of the cannula.
16. A tracheostomy assembly, comprising: a cannula comprising a
distal end and a proximal end, the distal end being adapted to be
inserted into a patient's trachea; a cap comprising an outer wall
and a nipple portion together defining an internal cavity
configured to be received by the proximal end of the cannula,
wherein the cannula is configured to be coupled to the cap such
that the nipple portion of the cap contacts in an inner diameter of
the cannula; and a flange configured to rest against a neck of the
patient and comprising an insert portion configured to be retained
in the internal cavity of the cap between the outer wall and the
proximal end of the cannula.
17. The tracheostomy assembly of claim 16, wherein the proximal end
of the cannula is flared and the nipple portion of the cap is
tapered to complement the flared end of the cannula.
18. The tracheostomy assembly of claim 16, wherein the nipple
portion of the cap comprises an annular protrusion configured to
create an interference fit between the nipple portion of the cap
and the proximal end of the cannula.
19. The tracheostomy assembly of claim 16, wherein the insert
portion of the flange comprises one or more annular protrusions
configured to create an interference fit between the outer wall of
the cap and the insert portion of the flange.
20. The tracheostomy assembly of claim 16, wherein the cap is made
of acrylonitrile butadiene styrene.
Description
BACKGROUND
[0001] The present disclosure relates generally to medical devices
and, more particularly, to airway devices, such as tracheostomy
tubes.
[0002] This section is intended to introduce the reader to various
aspects of art that may be related to various aspects of the
present disclosure, which are described and/or claimed below. This
discussion is believed to be helpful in providing the reader with
background information to facilitate a better understanding of the
various aspects of the present disclosure. Accordingly, it should
be understood that these statements are to be read in this light,
and not as admissions of prior art.
[0003] In the course of treating a patient, a tube or other medical
device may be used to control the flow of air, food, fluids, or
other substances into the patient. For example, medical devices,
such as tracheal tubes, may be used to control the flow of air and
medicaments into or out of a patient airway. In many instances, it
is desirable to provide a seal between the outside of the tube or
device and the interior of the passage in which the tube or device
is inserted. In this way, substances can only flow through the
passage via the tube or other medical device, allowing a medical
practitioner to maintain control over the type and amount of
substances flowing into and out of the patient.
[0004] More specifically, tracheal tubes may be used to control the
flow of air or other gases through a patient's trachea. Such
tracheal tubes may include endotracheal tubes or tracheostomy
tubes. While patients may be intubated using endotracheal tubes
during emergencies or shorter hospital stays, tracheostomy tubes
are typically used for prolonged ventilation, as the use of a
tracheostomy tube may be more comfortable for a patient.
[0005] A typical tracheostomy tube is generally inserted into the
trachea via a surgical incision in the neck. After insertion of the
tube into the trachea, a portion of the tracheostomy tube remains
outside the patient. This portion extends outwards from the neck
and may connect the tracheostomy tube to a ventilator or other
medical device. A stable attachment of the tracheostomy tube to the
desired external device is desirable since such a connection may be
instrumental in proper patient ventilation. Current designs for
tracheal tubes may allow for easy connection to a connector
associated with a desired external device but may have various
complex structures for conveying air between the connector and the
cannula extending into the patient. In some cases, difficulties may
exist in the mounting of the cannula in such devices, which must
interface with the connector portion of the external device to
provide the desired airflow path. Accordingly, there exists a need
for tracheostomy tubes that enable proper patient ventilation
without the drawbacks associated with current designs.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Advantages of the disclosed techniques may become apparent
upon reading the following detailed description and upon reference
to the drawings in which:
[0007] FIG. 1 is a perspective view of a tracheostomy tube assembly
including an assembled cap, flange, and cannula according to an
exemplary embodiment;
[0008] FIG. 2 is an exploded view of the tracheostomy tube assembly
of FIG. 1;
[0009] FIG. 3 is a sectional view of the cap of the embodiment of
FIG. 1 showing features of the cap in more detail;
[0010] FIG. 4 is a sectional view of the flange of the embodiment
of FIG. 1 showing features of the flange in more detail;
[0011] FIG. 5 is a sectional view of the tracheostomy tube assembly
of FIG. 1 illustrating internal features of the cap, the flange,
and the cannula when the three are joined in the integral
assembly;
[0012] FIG. 6 illustrates steps in an exemplary method that may be
utilized to form the exemplary tracheostomy tube assembly of FIG.
1; and
[0013] FIG. 7 illustrates an embodiment of an alternate method that
may be utilized to form the exemplary tracheostomy tube assembly of
FIG. 1.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0014] One or more specific embodiments of the present techniques
will be described below. In an effort to provide a concise
description of these embodiments, not all features of an actual
implementation are described in the specification. It should be
appreciated that in the development of any such actual
implementation, as in any engineering or design project, numerous
implementation-specific decisions must be made to achieve the
developers' specific goals, such as compliance with system-related
and business-related constraints, which may vary from one
implementation to another. Moreover, it should be appreciated that
such a development effort might be complex and time consuming, but
would nevertheless be a routine undertaking of design, fabrication,
and manufacture for those of ordinary skill having the benefit of
this disclosure.
[0015] As described in detail below, provided herein are a flange,
a cannula, and a cap that are configured to be coupled together to
provide embodiments of a unitary tracheostomy tube assembly. The
tracheostomy tube assemblies may be disposable or reusable, and may
be capable of conveying gas to and from the patient, such as during
medical situations that necessitate prolonged ventilation. As such,
the devices and techniques provided herein may enable maintenance
of a bidirectional gas flow between the patient and an external
ventilation device. Accordingly, the tracheostomy tube assemblies
provided herein may be adapted to be inserted into the trachea via
a surgical incision in the neck such that after insertion of the
tube into the trachea, a portion of tube remains outside the
patient. This portion extends outwards from the neck and may
connect the tracheostomy tube to a ventilator or other medical
device. That is, the provided tracheostomy tube assemblies may be
used in conjunction with auxiliary devices, such as airway
accessories, ventilators, humidifiers, and so forth, which may
cooperate with the tube assemblies to maintain airflow to and from
the lungs of the patient. To that end, the cap of the tracheostomy
tube assembly may be configured as a connector suitable for
attachment to an artificial ventilation system. For example, the
cap may be manufactured with an outer diameter dimension of
approximately 15 mm to conform to ISO standard dimensions of mating
connectors.
[0016] Turning now to the drawings, FIG. 1 is a perspective view of
an exemplary tracheal tube assembly 10 according to a presently
contemplated embodiment. In the illustrated embodiment, the
tracheal tube assembly is designed as a tracheostomy tube assembly,
although the present assembly techniques could be used in other
tubes, such as endotracheal tubes. In the depicted embodiment, the
tracheostomy tube assembly 10 includes an arcuate cannula 12 having
a proximal end 14 and a distal end 16, which is generally sized and
configured to be inserted into a patient's neck through a surgical
incision for prolonged ventilation. For example, in certain
embodiments, to conform more aptly to the patient anatomy, a curved
section may be provided in the cannula 12 as shown in FIG. 1. When
the tracheostomy tube assembly 10 is in use, the distal end 16 as
well as the major portion of the length of the cannula 12 will
reside within the trachea, with the proximal end 14 being generally
flush with the anterior surface of the patient's neck.
[0017] In some embodiments, the cannula 12 may also feature a small
lumen 18 within the wall, terminating in a notch 20 that may be
used to fill a balloon type sealing cuff 22 at the patient
insertion end. In some embodiments, the cuff 22 may be a urethane
balloon bonded to the exterior of the cannula 12 such that the
notch 20 is encompassed. In such embodiments, the cuff 22 may be
inflated within the patient's airway to provide an additional seal.
To that end, the cuff 22 may be connected to a cuff inflator valve
configured to deliver a gas, such as air, through the inflation
lumen 18 and into the cuff 22. The cuff 24, when inflated, will
expand radially around the cannula 12 to seal the patient's airway.
By using one or more cuffs 22 to seal the patient's airway,
substances may flow only through the cannula 12, which may allow
improved control over the type and amount of substances flowing
into and out of the patient as compared to tube assemblies without
one or more cuffs.
[0018] In some embodiments, the cannula 12 may also include a
suction lumen (not shown in FIG. 1) that extends from a location on
the proximal end 14 of the cannula 12 positioned outside the body
when in use to a location around the cuff 22 inside the body. The
suction lumen may terminate in a port through which secretions
accumulated around the cuff may be aspirated. For example, a port
may be located above the cuff 22 or one or more ports may be
located anywhere along the length of the cannula 12 such that their
placement facilitates aspiration of secretions from the airway of
the patient. Further, in some embodiments, an exterior suction tube
may connect to the suction lumen for the removal of the suctioned
fluids, for example, via a vacuum connected to the exterior suction
tube.
[0019] In the illustrated embodiment, the tracheostomy tube 10
further includes a cap 24 that is substantially in line with the
proximal end 14 of the cannula 12. The cap 24 may be adapted to
directly or indirectly connect the tracheostomy tube assembly 10 to
any suitable medical device. For example, in dual cannula
tracheostomy tubes, the collar 24 may serve as an insertion point
for a disposable cannula lining or may be suitably sized and shaped
to connect the tracheostomy tube assembly 10 via medical tubing,
suitable connectors, or other devices to a mechanical ventilator.
Various sizes of connections to such auxiliary devices are
available, and the cap 24 may be dimensioned to accommodate any one
of these sizes. For example, in certain embodiments, the cap 24 may
have an outer diameter of approximately 15 mm to conform to ISO
standard dimensions of mating connectors.
[0020] Side flanges 26 extend from the cap 24 for facilitating
securement of the trachesotomy tube assembly 10 to a patient. In
the case of the tracheostomy tube shown, the flanges 26 terminate
in apertures 28 through which straps or other attachment devices
may be inserted to secure the tracheostomy tube assembly 10 to the
patient's neck. It should be noted that certain arrangements that
incorporate the present teachings, such as endotracheal tubes, may
not be provided with flanges.
[0021] When the tracheostomy tube assembly 10 is in use, portions
of the cannula 12 and the flange 26 are retained within the body of
the cap 24 to provide a unitary or integral assembly 10. That is,
in embodiments disclosed herein, one or more features of the cap 24
may facilitate the integration of the cannula 12, the flange 26,
and the cap 24 into a single assembly, as described in more detail
below. As such, when assembled, an air passageway 30 is formed
through the cap 24 and extends through the cannula 12 such that,
when coupled to appropriate ventilation devices, air or other
gasses may be freely exchanged between a proximate end 32 of the
cap 24 and the distal end 16 of the cannula 12.
[0022] FIG. 2 is an exploded view of embodiments of components of
the tracheostomy tube assembly 10 that may include features capable
of securing the flange 26 and the cannula 12 to the cap 24. As
shown, the cap 24 includes a generally cylindrical body 34 having a
proximal end 32 and a distal end 36. The proximal end 32 includes
aperture 30 that extends throughout the body 34 and terminates in
an aperture (not shown in FIG. 2) provided at the distal end 36 of
the body 34. Such apertures are suitable for enabling a free flow
of fluids, such as air, throughout the length of the cap 24 when
assembled with the flange 26 and the cannula 12 during use in a
patient. Further, the cap 24 includes one or more features (not
shown in FIG. 2) provided in an interior wall of the aperture
extending throughout the body 34 and being adapted to engage
portions of the flange 26 and the cannula 12 when assembled, as
described in greater detail below. Still further, the diameter of
the cylindrical body 34 and the diameter of the aperture 30 of the
cap 24 may be dimensioned to accommodate various sized connectors
associated with suitable auxiliary equipment as desired for the
given application.
[0023] In the illustrated embodiment, the flange 26 includes
features complementary to those of the cap 24 and the cannula 12
that enable securement of such components together when assembled.
For example, the illustrated flange 26 includes an annular ridge 38
that is configured to receive the distal end 36 of the cap 24 about
the circumference of the ridge portion of the flange 26. For
further example, the flange 26 also includes outer annular
protrusions 40 that may be configured to engage with an inner
surface of the cap 24 to form an interference fit and a seal
between the flange 26 and the cap 24. Still further, the flange 26
also includes inner annular protrusions 42 configured to facilitate
the secure attachment of the flange 26 to the proximal end 14 of
the cannula 12.
[0024] The cannula 12 of the illustrated embodiment includes a
curved portion 44 that extends from the proximal end 14 to the
distal end 16 and may enable the tube assembly to conform to the
patient's anatomy when inserted into the patient's trachea. The
cannula 12 also includes a flared portion 46 at the proximal end
14, which may facilitate the attachment of the cannula 12 to one or
both of the cap 24 and the flange 26 when assembled. It should be
noted, however, that in other embodiments, the cannula 12 may not
include a flared portion or the flared portion may be formed during
the assembly of the components into a single assembly.
[0025] As appreciated by one skilled in the art, the cap 24, the
flange 26, and the cannula 12 may be formed from various suitable
materials via any appropriate manufacturing process. For example,
the cannula 12 may be formed from a soft polyvinyl chloride (PVC)
or another suitable plastic (e.g., polyurethane, thermoplastic
elastomers, etc.) through an extrusion process. Such materials may
enable a desirable contact fit between the cannula 12 and the cap
24 and/or the flange 26. Further, in certain embodiments, the
flange 26 may be made of a soft PVC molding, which may provide for
increased patient comfort when the flange 26 rests against the
patient's neck during use. In some embodiments, the cap 24 may be
made of a harder material than the flange 26 and the cannula 12,
such as a hard polyvinylchloride, a polycarbonate plastic, or any
other suitable material or combination of materials. For example,
in one embodiment, the cap 24 may be made of ABS, thus providing
rigidity to the cap 24, which may provide a rigid surface for
binding of the cannula 12 and the flange 26 as well as for
connecting the assembly to one or more auxiliary devices (e.g., a
connector associated with a ventilator).
[0026] FIG. 3 is a sectional view of the cap 24 illustrating a
variety of retention features disposed therein and configured to
facilitate the coupling of the cap 24 to the flange 26 and the
cannula 12. As shown, the cap 24 includes the body 34 through which
air passageway 30 extends from the top end 32 of the cap 24 to the
distal end 36 of the cap 24. As before, the passageway 30 enables
the free flow of fluids, such as air, lengthwise throughout the
body 34 of the cap 24. Along the length of the passageway 30, the
diameter of the passageway 30 tapers from the top end 32 toward the
bottom end 36 of the body 34. That is, a diameter 48 of the top
portion of the passageway 30 is greater than a second diameter 50
of the bottom portion of the passageway 30 to form an inner tapered
section 52 of the passageway 30. The inner tapered section 52
terminates in an inner uniform section 54 of substantially uniform
diameter approximately equal to diameter 50.
[0027] The cap 24 also includes inner surfaces 56 that are
configured to engage a top portion of the cannula 12 during
assembly as described in great detail below. The cap 24 further
includes outer tapered surfaces 58 terminating in protrusions 60.
The outer tapered surfaces 58 and the protrusions 60 may be
dimensioned to receive and retain the flared portion of the cannula
12 when a top portion of the flared end of the cannula 12 is seated
against inner surfaces 56. As such, the surface 56, the tapered
surface 58, and the protrusions 60 may form a nipple portion of the
cap body configured to be received by the proximal end of the
cannula such that the nipple portion of the cap is retained in the
inner diameter of the cannula. Still further, portions 62, which
extend annularly about the bottom portion 36 of the body 34, may be
sized and shaped to seat in a complementary ridge located on the
flange 26 to facilitate assembly.
[0028] FIG. 4 is a sectional view of an embodiment of the flange 26
illustrating features that may facilitate engagement of the flange
26 with the cannula 12 and the cap 24 during assembly. Similar to
the passageway 30 of the cap 24, the flange 26 also includes a
passageway 64 that is configured to couple to the passageway 30 of
the cap 24 and the cannula 12 to enable the airflow to and from the
patient during assembly. The flange 26 also includes inner annular
protrusion 42 that may engage the flared portion of the cannula 12
in some embodiments to create an interference fit and/or a suitable
seal between an inner tapered surface 66 of the passageway 64 and
an outer surface of the flared portion of the cannula 12 during
assembly. To that end, the inner tapered surface 66 may be
dimensioned to complement portions of the flared end of the desired
cannula 12 in some embodiments.
[0029] Further, the flange 26 also includes outer annular
protrusions 40 that may facilitate an interference fit and/or a
suitable seal between the outer surface of the flange 26 and an
inner surface of the cap 24 during assembly, as shown in more
detail in the embodiment of FIG. 5. Additional features, such as
annular ridge 38, may facilitate coupling of the cap 24 to the
flange 26 in the integrated assembly. When assembled and in use,
surfaces 68 of the flange 26 may be configured to rest against the
patient's neck to secure the assembly to the patient. As such,
additional features of the flange 26, such as the flexibility or
softness of the material from which the flange 26 is formed, may
increase patient comfort.
[0030] FIG. 5 is a cross sectional view of the assembled
tracheostomy tube assembly 10 illustrating assembly of the three
components to form an integral unit. As shown, during assembly, the
flared portion 46 of the cannula 12 is lodged between the inner
surface 66 of the flange 26 and the inner surface 58 of the cap 24.
The flared portion 46 of the cannula 12 may be coupled to the inner
surface 58 of the cap 24, for example, via any suitable bonding
agent, and to the inner surface 66 of the flange 26, for example,
via a solvent bond. Again, features of the flange 26, such as
annular protrusion 42, and features of the cap 24, such as surface
58 and annular protrusion 60 may facilitate the lodging of the
cannula 12 between portions of the cap 24 and portions of the
flange 26.
[0031] During assembly, portions of the flange 26 are retained
between portions of the cap 24 and the flared portion 46 of the
cannula 12. As previously mentioned, annular protrusion 42
facilitates the mating of the flange 26 and the flared portion 46
of the cannula 12. Similarly, annular protrusions 40 facilitate the
retention of the flange 26 within the cap 24 when the body 34 of
the cap 24 is in contact with the annular ridge 38. As appreciated
by one skilled in the art, the connection between the flange 26 and
the cap 24 may be secured via any suitable method, such as by the
application of a suitable adhesive (e.g., cyanoacrylate adhesive)
or through the use of a solvent bond, which may enable the
expansion of the annular protrusions 40 to create an appropriate
seal.
[0032] During assembly, a substantially sealed internal cavity 70
is formed within the cap 24. The internal cavity 70 may be filled
with air during use and, due to the substantially airtight seals
between the flange 26, the cannula 12, and the cap 24, in certain
embodiments, substances (e.g., bodily secretions) may be
substantially prevented from entering the sealed cavity 70. Still
further, in the illustrated embodiment, the cannula 12 includes a
notch 72 that may terminate in a lumen disposed in a wall of the
cannula 12, for example, to allow inflation of a cuff disposed near
the distal end 16 of the cannula 12. To that end, the illustrated
flange 26 includes an opening 74 dimensioned to facilitate
connection of the notch 72 to an externally located inflation
device.
[0033] As appreciated by one skilled in the art, the flange 26, the
cannula 12, and the cap 24 may be formed and assembled through
various suitable processes. As such, in some embodiments, the
components may be coupled together during manufacturing such that
the utilized adhesives and bonding processes do not necessitate the
use of backfilling, for example, with PVC. In other embodiments,
backfilling portions of the assembly with a suitable material may
be desirable as determined by the desired manufacturing and
assembly methods. FIGS. 6 and 7 illustrate embodiments of presently
contemplated methods of assembling and manufacturing the
illustrated tracheostomy tube assemblies. However, one skilled in
the art may employ any of a variety of suitable processes to form
and assemble the devices described herein.
[0034] Turning now to the method 76 illustrated in FIG. 6, the
method 76 includes the steps of extruding an unflared cannula
(block 78) and manufacturing the flange and cap from the desired
materials (block 80). The method 76 further includes dipping the
unflared cannula in a suitable solvent (block 82) and inserting the
first end of the cannula into the flange aperture (block 84). That
is, in this embodiment, the cannula and the flange are first
coupled to one another. After insertion of the cannula into the
flange, the inserted end of the cannula is flared (block 86), and
the top portion of the assembled flange and cannula is dipped in
solvent (block 88). Finally, a suitable adhesive is applied to the
inner portion of the cap (block 90), and the assembled flange and
cannula is inserted into the cap (block 92) to form the
tracheostomy tube assembly illustrated in FIG. 5.
[0035] Alternatively, the method 94 illustrated in FIG. 7 calls for
forming of a flared cannula (block 96) and manufacturing of the
flange and cap (block 98) before first coupling the flange and the
cap. To that end, after forming the components, adhesive is applied
to the nipple portion of the cap (block 100), and the pre-flared
portion of the cannula is bonded to the nipple portion of the cap
(block 102). Once the cannula and the cap are coupled, adhesive
material is applied to the flange (block 104), and the flange is
inserted into the assembled cap and cannula to form the
tracheostomy tube assembly of FIG. 5. Again, such manufacturing and
assembly methods are merely presently contemplated embodiments, and
one skilled in the art may employ any of a variety of suitable
methods to form the illustrated assemblies.
[0036] While the disclosure may be susceptible to various
modifications and alternative forms, specific embodiments have been
shown by way of example in the drawings and have been described in
detail herein. However, it should be understood that the
embodiments provided herein are not intended to be limited to the
particular forms disclosed. Rather, the various embodiments may
cover all modifications, equivalents, and alternatives falling
within the spirit and scope of the disclosure as defined by the
following appended claims.
* * * * *